FDA recall Z-1312-2024

Mckesson Medical-Surgical Inc. Corporate Office · Class II · device

Product

Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL

Reason for recall

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.

Distribution

US Nationwide distribution in the states of AZ, PA and TX.

Key facts

Status: Ongoing
Initiation date: 2024-01-09
Report date: 2024-03-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2024